Trial Outcomes & Findings for A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial (NCT NCT01617603)

Results Overview

HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index \> 2.4

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

84th day of product intake

Results posted on

2013-07-19

Participant Flow

62 subjects were recruited. The intention-to-treat (ITT) set comprised of all the subjects who completed V4. One subject joined another trial after recruitment while two other subjects dropped out in course of the trial. These three subjects were not included in the full analysis population. Finally, PP dataset comprised of n = 48.

Two subjects withdrew their consent quickly after giving it and were replaced so that the total number of recruited subjects was 62. Patients were randomly assigned to one of the three groups using age and gender as the stratification factors. The randomization was performed using the software TRIALSYS (developed internally at Nestlé).

Participant milestones

Participant milestones
Measure	High Polyphenol Milk Chocolate High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Low Polyphenol Milk Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin. Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Nestle Noir 70 % Chocolate Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given
Overall Study STARTED	20	21	21
Overall Study COMPLETED	17	19	20
Overall Study NOT COMPLETED	3	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison Chocolate With and Without High Cocoa Solids in Patients With Type 2 Diabetes in a Randomised Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Polyphenol Milk Chocolate n=20 Participants High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Low Polyphenol Milk n=21 Participants Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin. Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Nestle Noir 70 % Chocolate n=21 Participants Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Total n=62 Participants Total of all reporting groups
Age, Customized <= 45 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Age, Customized Between 45 and 75 years	20 participants n=5 Participants	21 participants n=7 Participants	21 participants n=5 Participants	62 participants n=4 Participants
Age, Customized >=75 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants	21 participants n=7 Participants	21 participants n=5 Participants	62 participants n=4 Participants
HOMA at the begining of product intake	6.50 HOMA index n=5 Participants	4.63 HOMA index n=7 Participants	4.45 HOMA index n=5 Participants	5.19 HOMA index n=4 Participants

PRIMARY outcome

Timeframe: 84th day of product intake

HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index \> 2.4

Outcome measures

Outcome measures
Measure	High Polyphenol Milk Chocolate n=17 Participants High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Low Polyphenol Milk n=19 Participants Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin. Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Nestle Noir 70 % Chocolate n=20 Participants Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given
Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake	2.82 HOMA index Interval 1.93 to 4.14	2.21 HOMA index Interval 1.5 to 3.26	2.75 HOMA index Interval 1.72 to 4.42

SECONDARY outcome

Timeframe: 84th day of product intake

Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 84th day of product intake

Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 84th day of product intake

Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake

Outcome measures

Outcome data not reported

Adverse Events

High Polyphenol Milk Chocolate

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Polyphenol Milk

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Nestle Noir 70 % Chocolate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Polyphenol Milk Chocolate n=20 participants at risk High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Low Polyphenol Milk n=21 participants at risk Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin. Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given	Nestle Noir 70 % Chocolate n=21 participants at risk Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given
Renal and urinary disorders Cyst resection	5.0% 1/20 • Number of events 1	0.00% 0/21	0.00% 0/21
Cardiac disorders Pacemaker installation	0.00% 0/20	4.8% 1/21 • Number of events 1	0.00% 0/21

Other adverse events

Adverse event data not reported

Additional Information

Prof. Stephen Atkin, Principal Investigator

Medical School, Michael White Diabetes Centre, 220-236, Anlaby Road,

Phone: +44(0)1482 675312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER